Patients receiving lower-dose diclofenac experienced significant postoperative pain relief compared to those receiving a placebo, according to Phase 3 trial results from Iroko Pharmaceuticals. Researchers presented the data at the 54th Annual Meeting of the American Headache Society in Los Angeles last week.
In the 428-patient study, both the 18mg and 35mg doses of lower-dose diclofenac demonstrated significant improvement in pain relief over 48 hours using a visual analog scale in patients with acute pain. Pain relief scores were 524 for the 35mg dose, 393 for the 18mg dose and 390 for the control, celecoxib, which included an initial 400mg dose followed by 200mg twice per day.
"These pivotal data indicate that submicron particle diclofenac may provide effective pain relief at a lower dose while offering fast onset of action," stated Stephen Silberstein, professor of neurology and director of the Jefferson Headache Center at Thomas Jefferson University in Philadelphia. "In meeting this important study objective, this newly formulated diclofenac could represent a meaningful advance in the management of pain."
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In the 428-patient study, both the 18mg and 35mg doses of lower-dose diclofenac demonstrated significant improvement in pain relief over 48 hours using a visual analog scale in patients with acute pain. Pain relief scores were 524 for the 35mg dose, 393 for the 18mg dose and 390 for the control, celecoxib, which included an initial 400mg dose followed by 200mg twice per day.
"These pivotal data indicate that submicron particle diclofenac may provide effective pain relief at a lower dose while offering fast onset of action," stated Stephen Silberstein, professor of neurology and director of the Jefferson Headache Center at Thomas Jefferson University in Philadelphia. "In meeting this important study objective, this newly formulated diclofenac could represent a meaningful advance in the management of pain."
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